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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number 10291734
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Microcysts, Epithelial (2232); Ulcer (2274)
Event Type  Injury  
Manufacturer Narrative
The complaint product was returned for evaluation and was found to meet manufacturing specifications. The device history record and sterilization record for this lot have been reviewed and found to be in compliance. The manufacturing review did not indicate that this complaint was due to the manufacturing process. No complaint or manufacturing trend was identified. The root cause could not be determined. (b)(4). Updated manufacturing date- 02/20/2016. (b)(4).
 
Manufacturer Narrative
The complaint sample has been returned for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
 
Event Description
As initially reported on 04/12/2017, a consumer experienced epithelial loss and a surface ulcer. At the time of report, the consumer's eye condition was unknown. Additional information was received on 04/17/2017, the health professional reported that all symptoms had resolved and the consumer was currently wearing eye glasses. Additional information was requested but not yet received.
 
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Brand NameAIR OPTIX AQUA MULTIFOCAL
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer (Section G)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6559719
MDR Text Key112584549
Report Number3006186389-2017-00036
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Lot Number10291734
Other Device ID Number000000000010073881-155700172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/11/2017 Patient Sequence Number: 1
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